Manufacturing Process Engineer

Job Description

This position serves as a subject-matter-expert and provides real-time, process engineering support to the manufacturing process. It involves designing, project managing, and implementing changes, improvements, new systems and/or equipment. The role also includes leading/assisting in Continuous Improvement Projects, developing and modifying Standard Operating Procedures (SOPs), and participating in deviation investigations.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Chemical Engineering
• Minimum 3-5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred)
• Expertise in troubleshooting production equipment/systems
• Ability to work flexible schedule to support 24-hour operation (requires assignment on shift for 4 shift rotating days off schedule)
• PC literate with standard office applications (Word, Excel, PowerPoint) competency
• Experience with maintenance and administration of both Windows-based and industrial (e.g., PLC) computer networks
• Experience with Allen-Bradley ControlLogix and Siemens PLCs; experience with HMI software applications; experience with automating processes and equipment
• Knowledge and understanding of cGMPs including FDA, PMDA, and EU regulations; knowledge of cGMP validation requirements and techniques; experience with commissioning and validation protocol development and execution
• Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques